Group Pushes FDA to Announce Medical Device Tracking Program

Apr 4, 2008 | Parker Waichman LLP

The Food & Drug Administration (FDA) is taking too long to announce and implement a program to track medical devices, a coalition of health care advocacy groups said. Implementation of an identification system that assigns a medical device unique number will mean quicker and more reliable recalls and better tracking of outcomes in patients who have implanted devices, the group says.

Every year, dozens of medical devices are recalled due to dangerous defects. One of the challenges of such medical device recalls is informing patients with implantable devices that they are the subject to a recall. A standardized medical device tracking system would help streamline this process.

The Food and Drug Administration Amendments Act of 2007, which passed in October, included legislation requiring the implementation of a unique identification system for devices but did not specify a time frame in which such a system must be in place. Known as unique device identification, such a system will enable bar coding and other electronic tracking systems for medical devices. Advocates of such a system say it is critical to improving patient safety, reducing medical errors, enhancing medical device recall processes and improving device adverse event reporting. The FDA has been consulting with industry stakeholders on such a rule since 2005 and in recent months has come under pressure to finish the task.

In a letter to the FDA dated March 26, the Advanced Patient Safety Coalition - made up of hospitals, patient advocacy groups, and clinicians - called unique medical device identification “a crucial factor” in improving patient safety and reducing the frequency of medical errors.

“We need to be able to track medical devices like we can track any other product,” Blair Childs, senior vice president at Premier Inc., of Charlotte, N. C., and a member of the coalition, told GovernmentHealthIT.com. “We can track spinach that has E. coli back to the field where it was grown, but we can’t track a recalled medical device because there is no unique numbering system.”

Child's said there has been a growing sense of urgency among advocates of the medical device tracking system because the FDA has given no indication as to when such a tracking system might be implemented. Even once the FDA announces the new system, it will take time for it to become a reality. Once the proposed rule appears in the Federal Register, it must go through a 60-day comment period and potential FDA adjustments.

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